Ethambutol Hydrochloride

Product NDC: 68850-004
11-digit product format: 688500004
Labeler code: 68850
Product ID: 68850-004_f8939d3c-f0f7-4fb3-baf6-6b150c426f50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ethambutol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: STI Pharma
Application: NDA016320
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2006-12-15
Marketing end: 0000-00-00
Substance: ETHAMBUTOL HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Antimycobacterial [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68850-004		I	Inactivated by FDA		2026-08-11
excluded package	package	68850-004	68850-004-01	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68850-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68850-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68850-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68850-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68850-004-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68850-004-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68850-004-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68850-004-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68850-004-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68850-004-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68850-004-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68850-004-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68850-004-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68850-004-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68850-004-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68850-004-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68850-004-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68850-004-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68850-004-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68850-004-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68850-004-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68850-004-01	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N016320-001	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982
N016320-002	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	200MG	TABLET / ORAL		Approved before 1982
N016320-003	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N016320-004	MYAMBUTOL	ETHAMBUTOL HYDROCHLORIDE	500MG	TABLET / ORAL		Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N016320-001	AB
N016320-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016320-001	MYAMBUTOL	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-002	MYAMBUTOL	200MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-003	MYAMBUTOL	400MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-004	MYAMBUTOL	500MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016320-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016320-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016320-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016320-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016320-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016320-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016320-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016320-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016320-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016320-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016320-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016320-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016320-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016320-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016320-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016320-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016320-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016320-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016320-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016320-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016320-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016320-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016320-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016320-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016320-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016320-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016320-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016320-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016320-003	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e86e15b7-896a-6fb4-16e3-cf6efd994b64	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68850-004-01	2019-11-13	C162847	48780-1	97449f38-bd83-f6ea-e053-dbdaa90aa703	Ethambutol Hydrochloride TABLETS USP 100 mg and 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68850-004-01	Ethambutol Hydrochloride	12 in 1 CARTON	TABLET, FILM COATED	12		2
68850-004-01	Ethambutol Hydrochloride	12 in 1 BOX	TABLET, FILM COATED	12		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68850-004-01	EA - Each	68850-004	b4509925-67aa-4b91-9d01-87506a50fdb2	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ethambutol Hydrochloride	ACTIVE INGREDIENT	QE4VW5FO07	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Ethambutol	ACTIVE MOIETY	8G167061QZ	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Gelatin	INACTIVE INGREDIENT	2G86QN327L	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Sucrose	INACTIVE INGREDIENT	C151H8M554	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68850-004	ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA]	2	Legacy NDC, 2 package rows	20120817_d123fbd1-57de-47c6-963f-54d69427290b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	STI Pharma LLC	3f6428d6-3745-4337-ad78-ebfff9f49135	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016320 application number: NDA016320
Ethambutol Hydrochloride	ETHAMBUTOL HYDROCHLORIDE	Kanchan Healthcare Inc	e4ccab0e-84ff-447f-82ca-fa0a3989f6b7	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016320 application number: NDA016320
ETHAMBUTOL HYDROCHLORIDE	ETHAMBUTOL HYDROCHLORIDE	Marlex Pharmaceuticals, Inc.	1b9fbe16-edfc-44b6-b8d8-5c5a9d7558e1	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016320 application number: NDA016320

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QE4VW5FO07	ETHAMBUTOL HYDROCHLORIDE	1070-11-7	ETHAMBUTOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995599	ethambutol HCl 100 MG Oral Tablet	PSN	d123fbd1-57de-47c6-963f-54d69427290b	2
995607	ethambutol HCl 400 MG Oral Tablet	PSN	d123fbd1-57de-47c6-963f-54d69427290b	2
995599	ethambutol hydrochloride 100 MG Oral Tablet	SCD	d123fbd1-57de-47c6-963f-54d69427290b	2
995607	ethambutol hydrochloride 400 MG Oral Tablet	SCD	d123fbd1-57de-47c6-963f-54d69427290b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68850-004-01	68850000401	12 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ethambutol Hydrochloride TABLETS USP 100 mg and 400 mg	STI Pharma \| Patheon Inc.	2012-08-16	HUMAN PRESCRIPTION DRUG LABEL	2